The following data is part of a premarket notification filed by Alcon Laboratories, Inc. with the FDA for Customcornea Measurement Device (ccmd).
Device ID | K000637 |
510k Number | K000637 |
Device Name: | CUSTOMCORNEA MEASUREMENT DEVICE (CCMD) |
Classification | Aberrometer, Ophthalmic |
Applicant | ALCON LABORATORIES, INC. 2800 DISCOVERY DR., Orlando, FL 32826 -3714 |
Contact | S.k. Mcgarvey |
Correspondent | S.k. Mcgarvey ALCON LABORATORIES, INC. 2800 DISCOVERY DR., Orlando, FL 32826 -3714 |
Product Code | NCF |
CFR Regulation Number | 886.1760 [🔎] |
Decision | Se - With Limitations (SESU) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-02-25 |
Decision Date | 2000-05-19 |